Content about Clinical research

March 21, 2012
FDA advisory committee votes in favor of GSK's Votrient

A Food and Drug Administration expert panel delivered a favorable vote on a cancer drug made by GlaxoSmithKline.

PHILADELPHIA — A Food and Drug Administration expert panel delivered a favorable vote on a cancer drug made by GlaxoSmithKline.

GSK announced that the FDA Oncologic Drugs Advisory Committee voted 11-2 that clinical trial data indicated a favorable risk-benefit profile of the drug Votrient (pazopanib) in patients with advanced soft-tissue sarcoma who have received chemotherapy. The drug is already approved for treating the kidney cancer renal cell carcinoma.

March 16, 2012
Amerigen joins Bystolic patent challenge

Another generic drug maker has joined efforts to challenge the patent on a drug made by Forest Labs for treating hypertension.

NEW YORK — Another generic drug maker has joined efforts to challenge the patent on a drug made by Forest Labs for treating hypertension.

March 16, 2012
Patients taking oral cancer drugs may risk drug interactions, study finds

Pills for treating cancer have created numerous alternatives to spending hours in a clinic or at home receiving chemotherapy infusions, but risks of drug interactions remain, according to a new survey by the research arm of pharmacy benefit manager Medco Health Solutions.

WASHINGTON — Pills for treating cancer have created numerous alternatives to spending hours in a clinic or at home receiving chemotherapy infusions, but risks of drug interactions remain, according to a new survey by the research arm of pharmacy benefit manager Medco Health Solutions.

March 15, 2012
Late-stage trial of MS drug shows positive results

A drug under investigation by Teva Pharmaceutical Industries and Active Biotech reduced symptoms and progression of disease in patients with multiple sclerosis, according to results of a late-stage clinical trial.

JERUSALEM — A drug under investigation by Teva Pharmaceutical Industries and Active Biotech reduced symptoms and progression of disease in patients with multiple sclerosis, according to results of a late-stage clinical trial.

Teva and Active announced the publication of results of the phase-3 "Allegro" study of oral laquinimod in the March 15 issue of the New England Journal of Medicine. The study was conducted in 24 countries and enrolled 1,106 patients with MS who received 0.6 mg of laquinimod per day or placebo.

March 14, 2012
Endo seeks tougher standards for generic versions of Lidoderm

Endo Pharmaceuticals is hoping the Food and Drug Administration will back tougher regulatory approval requirements for generic versions of one of its drugs.

CHADDS FORD, Pa. — Endo Pharmaceuticals is hoping the Food and Drug Administration will back tougher regulatory approval requirements for generic versions of one of its drugs.

March 14, 2012
Forest files suit over generic versions of hypertension drug

Forest Labs has filed suit against Glenmark Generics and several other companies, alleging that they infringed on its patent for a drug to treat hypertension by seeking regulatory approval for generic versions.

NEW YORK — Forest Labs has filed suit against Glenmark Generics and several other companies, alleging that they infringed on its patent for a drug to treat hypertension by seeking regulatory approval for generic versions.

Forest and Johnson & Johnson subsidiary Janssen Pharmaceutica NV have sued Glenmark, Hetero USA, Torrent Pharmaceuticals and Watson Labs in response to their filing regulatory approval applications with the Food and Drug Administration for generic versions of Bystolic (nebivolol).

March 12, 2012
Watson starts phase-3 trial of Esmya

Drug maker Watson Pharmaceuticals has started a late-stage trial of a drug made to treat benign tumors of the uterus, the company said Monday.

PARSIPPANY, N.J. — Drug maker Watson Pharmaceuticals has started a late-stage trial of a drug made to treat benign tumors of the uterus, the company said Monday.

Watson announced the initiation of a phase-3 trial of Esmya (ulitristal acetate) in women who have anemia due to uterine leimyomas, also known as uterine fibroids, which causes benign solid tumors that can lead to excessive menstrual bleeding, anemia and pain and may require surgery. Watson is developing the drug under a licensing agreement with Gedeon Richter.

March 7, 2012
FDA turns down Eisai drug application

The Food and Drug Administration has declined to approve a drug made by Eisai for leukemia in certain elderly patients, the drug maker said.

WOODCLIFF LAKE, N.J. — The Food and Drug Administration has declined to approve a drug made by Eisai for leukemia in certain elderly patients, the drug maker said.

Eisai said the FDA delivered it a complete response letter for the chemotherapy drug Dacogen (decitabine) in patients ages 65 years and older with acute myeloid leukemia who are not candidates for induction therapy. The FDA delivers a complete response letter when questions remain about an regulatory application that preclude approval, usually due to insufficient clinical trial data.

March 7, 2012
Forest, Pierre Fabre drug 'significantly' reduced depression symptoms

A drug under development by Forest Labs and Pierre Fabre "significantly" reduced symptoms of major depressive disorder, the companies said Wednesday.

NEW YORK — A drug under development by Forest Labs and Pierre Fabre "significantly" reduced symptoms of major depressive disorder, the companies said Wednesday.

New York-based Forest and Paris-based Pierre Fabre announced results of a phase-3 trial of levomilnacipran, saying the drug showed reductions in symptoms as early as one week after treatment was started. The companies expect results of another phase-3 trial of the drug this spring.

March 6, 2012
Takeda unit starts trial of lymphoma drug

Takeda Pharmaceutical's cancer drug unit has started a late-stage clinical trial of a drug for treating a rare form of lymphoma, the company said.

CAMBRIDGE, Mass. — Takeda Pharmaceutical's cancer drug unit has started a late-stage clinical trial of a drug for treating a rare form of lymphoma, the company said.

The unit, Millennium, announced the start of a phase-3 trial to evaluate MLN8237 in patients with relapsed or refractory peripheral T-cell lymphoma, an aggressive non-Hodgkin's lymphoma.

March 5, 2012
Study finds Teva allergy drug safe, effective

A drug under development by Teva Pharmaceutical Industries appears safe and effective in treating allergies, according to results of a late-stage clinical trial released Monday.

JERUSALEM — A drug under development by Teva Pharmaceutical Industries appears safe and effective in treating allergies, according to results of a late-stage clinical trial released Monday.

Teva said a 529-patient phase-3 trial of Qnasl (beclomethasone dipropionate) nasal aerosol showed the drug produced a "significant" improvement in patients with seasonal and perennial allergies. Patients received either 320 mcg of Qnasl or a placebo.

March 1, 2012
FDA approves two new drugs for pancreatic disorders

The Food and Drug Administration has approved two new drugs for pancreatic disorders, the agency said Thursday.

SILVER SPRING, Md. — The Food and Drug Administration has approved two new drugs for pancreatic disorders, the agency said Thursday.

The FDA announced the approval of Aptalis Pharma's Ultresa and Viokase, both generically known as pancrelipase. Ultresa is a delayed-release capsule for children and adults with cystic fibrosis, which affects the lungs and other organs, while Viokase is meant for use with a proton-pump inhibitor in adults who can't digest food because of pancreatitis or surgical removal of the pancreas.

February 29, 2012
CVS Caremark's Accordant Health Services to collaborate with Michael J. Fox Foundation

Accordant Health Services, a CVS Caremark company, and the Michael J. Fox Foundation for Parkinson's Research on Wednesday announced a collaboration to provide to patients with Parkinson's disease who are enrolled in Accordant-sponsored care management programs information about resources available through the foundation.

WOONSOCKET, R.I., and NEW YORK  — Accordant Health Services, a CVS Caremark company, and the Michael J. Fox Foundation for Parkinson's Research on Wednesday announced a collaboration to provide to patients with Parkinson's disease who are enrolled in Accordant-sponsored care management programs information about resources available through the foundation.

February 28, 2012
FDA grants priority review to J&J heart drug

The Food and Drug Administration has given priority review to a regulatory application from Johnson & Johnson for a drug designed to reduce the risk of complications from internal blood clots.

RARITAN, N.J. — The Food and Drug Administration has given priority review to a regulatory application from Johnson & Johnson for a drug designed to reduce the risk of complications from internal blood clots.

J&J's Janssen Research & Development division announced that the FDA had given the designation to Xarelto (rivaroxaban), an oral anticoagulant, to reduce the risk of certain types of heart attacks in patients with acute coronary syndrome, which 1.2 million Americans are diagnosed with every year.

February 24, 2012
Par completes acquisition of Edict

Generic drug maker Par Pharmaceutical has completed its acquisition of an Indian drug company, Par said.

WOODCLIFF LAKE, N.J. — Generic drug maker Par Pharmaceutical has completed its acquisition of an Indian drug company, Par said.

Par announced that it had completed its $20.5 million acquisition of Chennai, India-based Edict Pharmaceuticals.

Edict specializes in oral solid drugs and currently has 11 regulatory approval applications under review at the Food and Drug Administration.

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February 23, 2012
FDA accepts NDA filing for Impax's Parkinson's disease treatment

The Food and Drug Administration has accepted a new drug application for the treatment of idiopathic Parkinson’s disease.

HAYWARD, Calif. — The Food and Drug Administration has accepted a new drug application for the treatment of idiopathic Parkinson’s disease.

Impax Pharmaceuticals, the branded products division of Impax Labs, said it filed its NDA for the investigational drug IPX066, an extended-release capsule formulation of carbidopa-levodopa, for review in December 2011. IPX066 has been licensed to GlaxoSmithKline for countries outside the United States and Taiwan for development and marketing.

February 23, 2012
FDA approves Korlym for Cushing's syndrome

The Food and Drug Administration has approved a drug for a rare disorder that previously had no approved medical therapies, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug for a rare disorder that previously had no approved medical therapies, the agency said.

The FDA announced the approval of Menlo Park, Calif.-based Corcept Therapeutics' Korlym (mifepristone) for endogenous Cushing's syndrome, a disorder that results from overproduction of cortisol, a steroid hormone that increases blood-sugar levels.

February 21, 2012
FDA moves to address cancer drug shortages

An executive order from the Obama administration has spurred the Food and Drug Administration to address shortages of two cancer drugs and issue draft guidance for the industry to help prevent future shortages, the agency said Tuesday.

SILVER SPRING, Md. — An executive order from the Obama administration has spurred the Food and Drug Administration to address shortages of two cancer drugs and issue draft guidance for the industry to help prevent future shortages, the agency said Tuesday.

February 21, 2012
Pfizer inks generics deal with Chinese drug maker

Pfizer has signed a deal worth more than $500 million with a Chinese drug maker to make generic drugs for China and other markets, the companies said.

NEW YORK — Pfizer has signed a deal worth more than $500 million with a Chinese drug maker to make generic drugs for China and other markets, the companies said.

Pfizer announced the joint venture with Zhejiang Hisun Pharmaceutical to develop, manufacture and commercialize generic drugs. Hisun will invest $295 million into the venture — called Hisun Pfizer Pharmaceutical Co. — and own a 51% stake, while Pfizer will invest $250 million and own 49%.

February 13, 2012
Columbia Labs transfers NDA for reproductive drug to Watson

Columbia Labs has transferred a new drug application for a topical drug designed to prevent premature birth in pregnant women to Watson Pharmaceuticals.

LIVINGSTON, N.J. and PARSIPPANY, N.J. — Columbia Labs has transferred a new drug application for a topical drug designed to prevent premature birth in pregnant women to Watson Pharmaceuticals.

Columbia Labs said Watson now has full rights and regulatory responsibility for all activities and sponsor obligations relating to the application for progesterone vaginal gel 8%. Late last month, the drug received a thumbs-down from an FDA panel that declined to recommend approval for it.

The FDA is expected to take action on the NDA by Feb. 26.

February 9, 2012
FDA approves Mylan antimicrobial drug

The Food and Drug Administration has approved an antimicrobial drug made by Mylan, the drug maker said Thursday.

PITTSBURGH — The Food and Drug Administration has approved an antimicrobial drug made by Mylan, the drug maker said Thursday.

The FDA approved Mylan's doxycycline hyalite delayed-release tablets in the 150-mg strength. The drug is a generic version of Warner Chilcott's Doryx.

February 9, 2012
FDA releases draft guidance for biosimilars

The Food and Drug Administration reached a major milestone on the path to a regulatory regime for follow-on biologics on Thursday with the release of draft guidance on biosimilar product development.

SILVER SPRING, Md. — The Food and Drug Administration reached a major milestone on the path to a regulatory regime for follow-on biologics on Thursday with the release of draft guidance on biosimilar product development.

February 1, 2012
Lipitor foreshadows approaching patent cliff for other leading drugs

For the past several years, drug industry experts have spoken in terms of the “patent cliff,” the period when the patents covering several blockbuster drugs are set to expire, thus leaving their manufacturers with a big, gaping hole in their revenues as those drugs face competition from generics.

For the past several years, drug industry experts have spoken in terms of the “patent cliff,” the period when the patents covering several blockbuster drugs are set to expire, thus leaving their manufacturers with a big, gaping hole in their revenues as those drugs face competition from generics.

January 31, 2012
FDA approves Hi-Tech Pharmacal's anxiety drug

The Food and Drug Administration has approved a generic drug for anxiety made by Hi-Tech Pharmacal, the drug maker said Tuesday.

AMITYVILLE, N.Y. — The Food and Drug Administration has approved a generic drug for anxiety made by Hi-Tech Pharmacal, the drug maker said Tuesday.

The FDA approved Hi-Tech's lorazepam oral concentrate in the 2-mg-per-mL strength, a generic version of Roxanne Labs' Intensol.

Branded and generic versions of the drug had sales of $10 million in 2011, according to IMS Health.

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January 26, 2012
Amgen acquiring Micromet for $1.16 billion

Drug maker Amgen is acquiring a Rockville, Md.-based company developing therapies for cancer, the companies said Thursday.

THOUSAND OAKS, Calif. — Drug maker Amgen is acquiring a Rockville, Md.-based company developing therapies for cancer, the companies said Thursday.

Amgen announced plans to buy Micromet for $1.16 billion, or $11 per share. Micromet, originally founded in Germany, is developing blinatumomab, currently in phase-2 trials as a treatment for acute lymphoblastic leukemia and non-Hodgkin's lymphoma. The acquisition also will include the company's research and development center in Munich.